RxNorm Names
ADVIL
(ibuprofen)
capsule, liquid filled
[Pfizer Consumer Healthcare]
Permanent Link:
http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=1f01c10a-9434-91a4-2ee4-352315a6b610| Category | DEA Schedule | Marketing Status |
|---|---|---|
| HUMAN OTC DRUG LABEL | New Drug Application |
ACTIVE INGREDIENT (IN EACH CAPSULE)
Solubilized ibuprofen equal to 200 mg ibuprofen (NSAID)*
USES
- temporarily relieves minor aches and pains due to:
- headache
- toothache
- backache
- menstrual cramps
- the common cold
- muscular aches
- minor pain of arthritis
- temporarily reduces fever
WARNINGS
Allergy alert:
Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:
- hives
- facial swelling
- asthma (wheezing)
- shock
- skin reddening
- rash
- blisters
If an allergic reaction occurs, stop use and seek medical help right away.
Stomach bleeding warning:
This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you
- are age 60 or older
- have had stomach ulcers or bleeding problems
- take a blood thinning (anticoagulant) or steroid drug
- take other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others]
- have 3 or more alcoholic drinks every day while using this product
- take more or for a longer time than directed
Do not use
- if you have ever had an allergic reaction to any other pain reliever/fever reducer
- right before or after heart surgery
Ask a doctor before use if
- stomach bleeding warning applies to you
- you have problems or serious side effects from taking pain relievers or fever reducers
- you have a history of stomach problems, such as heartburn
- you have high blood pressure, heart disease, liver cirrhosis, kidney disease, or asthma
- you are taking a diuretic
Ask a doctor or pharmacist before use if you are
- under a doctor's care for any serious condition
- taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin
- taking any other drug
When using this product
- take with food or milk if stomach upset occurs
- the risk of heart attack or stroke may increase if you use more than directed or for longer than directed
Stop use and ask a doctor if
- you experience any of the following signs of stomach bleeding:
- feel faint
- vomit blood
- have bloody or black stools
- have stomach pain that does not get better
- pain gets worse or lasts more than 10 days
- fever gets worse or lasts more than 3 days
- redness or swelling is present in the painful area
- any new symptoms appear
DIRECTIONS
- do not take more than directed
- the smallest effective dose should be used
- adults and children 12 years and over: take 1 capsule every 4 to 6 hours while symptoms persist
- if pain or fever does not respond to 1 capsule, 2 capsules may be used
- do not exceed 6 capsules in 24 hours, unless directed by a doctor
- children under 12 years: ask a doctor
OTHER INFORMATION
- each capsule contains: potassium 20 mg
- read all warnings and directions before use. Keep carton.
- store at 20-25°C (68-77°F)
- avoid excessive heat above 40°C (104°F)
INACTIVE INGREDIENTS
FD&C green no. 3, gelatin, light mineral oil, pharmaceutical ink, polyethylene glycol, potassium hydroxide, purified water, sorbitan, sorbitol
PRODUCT PACKAGING
The product packaging shown below represents a sample of that currently in use. Additional packaging may also be available.
Solubilized Ibuprofen Capsules, 200 mg
Pain Reliever/Fever Reducer (NSAID)
80 Liqui-Gels* *Liquid Filled Capsules
Madison, NJ 07940 USA ©2011 Pfizer Inc.
LIQUI-GELS is a trademark or registered trademark of Catalent Pharma Solutions.

| ADVIL
ibuprofen capsule, liquid filled |
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Labeler - Pfizer Consumer Healthcare (828831730) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
| Catalent Pharma Solutions, LLC | 051762268 | ANALYSIS(0573-0169), MANUFACTURE(0573-0169), PACK(0573-0169), REPACK(0573-0169) | |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
| Catalent Argentina S.A.I.C. | 970545174 | MANUFACTURE(0573-0169) | |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
| Fareva Richmond, Inc. | 969523245 | ANALYSIS(0573-0169), LABEL(0573-0169), MANUFACTURE(0573-0169), PACK(0573-0169), RELABEL(0573-0169), REPACK(0573-0169) | |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
| Wyeth Pharmaceuticals Company, Consumer Site | 829390975 | ANALYSIS(0573-0169), LABEL(0573-0169), MANUFACTURE(0573-0169), PACK(0573-0169) | |
Review RxNorm Normal Forms